TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM— 510(k) K043452

Substantially Equivalent

Sonosite,Inc.

FDA 510(k) clearance K043452 for TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM, Substantially Equivalent on 2004-12-21. Applicant: Sonosite,Inc..

Clearance details

Applicant: Sonosite,Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2004-12-15
Decision date: 2004-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

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Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.